ONWARD® Medical hosts webcast to discuss details of

Results of the Up-LIFT approval study published in Nature Medicine

Discussing the results of the pivotal study in a webcast this week with company executives, study leaders and participants

EINDHOVEN, Netherlands, May 22, 2024 (GLOBE NEWSWIRE) — ONWARD Medical NV (Euronext: ONWD), the medical device company developing innovative spinal cord stimulation therapies to restore movement, function and independence to people with spinal cord injury (SCI), today announced that following a brief Q1 business update, CEO Dave Marver will host a review of the Up-LIFT pivotal trial results with a panel of company executives, principal investigators and study participants on Thursday, May 23 at 2:30 p.m. CET/8:30 a.m. ET. The Up-LIFT trial demonstrated the safety and efficacy of ARC-EX external therapy to improve hand and arm function following spinal cord injury.

Panelists include Up-LIFT study principal investigators Dr. Jim Guest, Dr. Chet Moritz and Dr. Candace Tefertiller, study participants Sherown Campbell and Jessie Owen, and Erika Ross Ellison, VP Clinical, Regulatory and Quality at ONWARD Medical.

To join the webcast via Zoom, please register using this link.

Participants can also dial in by telephone:

+32 2 290 9360 (Belgium)

+33 1 7037 2246 (France)

+49 69 3807 9884 (Germany)

+31 20 794 0854 (Netherlands)

+41 22 591 0156 (Switzerland)

+44 203 481 5240 (United Kingdom)

+1 346 248 7799 (US)

Additional phone numbers are available

Meeting ID: 879 5741 2479

A replay of the webcast will be available on the Company’s website following the live event.

To learn more about ONWARD Medical’s commitment to partnering with the SCI community to develop innovative solutions to restore movement, function and independence after spinal cord injury, please visit ONWD.com.

* All medical devices and therapies from ONWARD^® Medical, including but not limited to ARC-IM^®ARC-EX^®ARC-BCI™ and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.

About ONWARD Medical

ONWARD^® Medical is a medical technology company developing therapies to restore movement, function and independence for people with spinal cord injury (SCI) and movement disorders. Based on more than a decade of scientific discovery, preclinical and clinical research at leading hospitals, rehabilitation clinics and neuroscience laboratories, the company has developed ARC Therapy™, which has been awarded ten Breakthrough Device Designations by the U.S. Food and Drug Administration (FDA).

ONWARD ARC therapy is a targeted, programmed stimulation of the spinal cord, which is delivered via the external ARC-EX^®– or implantable ARC-IM^®platforms. ARC therapy can also be delivered using the Company’s ARC-BCI™ platform, which combines the ARC-IM system with brain-computer interface (BCI) technology to restore movement after spinal cord injury using thought-based control.

The use of non-invasive ARC-EX therapy significantly improved upper limb function after spinal cord injury in the global, pivotal Up-LIFT study; results were published in May 2024 in Natural Medicine The company has submitted a New Drug Application to the FDA for the ARC-EX system in the US and is preparing for submission in Europe. In parallel, the company is conducting clinical trials with its ARC-IM therapy, which has demonstrated positive interim clinical results for improved blood pressure regulation following spinal cord injury. Additional ongoing clinical trials focus on the use of ARC-IM therapy to improve mobility following spinal cord injury and gait disturbances in Parkinson’s disease, as well as the use of the ARC-BCI platform to restore mind-controlled movement of the upper and lower limbs following spinal cord injury.

ONWARD Medical is headquartered in Eindhoven, the Netherlands, with a science and development center in Lausanne, Switzerland, and a U.S. office in Boston, Massachusetts. The company is listed on Euronext Brussels and Amsterdam (ticker: ONWD).

For more information, visit ONWD.com, LinkedIn, and YouTube.

For media inquiries:
Aditi Roy, VP Communications
[email protected]

For investor inquiries:
Amori Fraser, Finance Director
[email protected]

Disclaimer

Certain statements, beliefs and opinions in this press release are forward-looking and reflect the current expectations and projections of the Company or the Company’s directors with respect to future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could affect the outcome and financial impact of the plans and events described herein. A variety of factors, including, but not limited to, changes in demand, competition and technology, could cause actual events, performance or results to differ materially from those anticipated. Forward-looking statements in this press release that address past trends or activities are not representations that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to the forward-looking statements contained in this press release to reflect any change in expectations or any change in events, conditions, assumptions or circumstances on which the forward-looking statements are based. Neither the Company, nor its advisors or agents, nor any of its affiliates, nor the officers or employees of any of these persons warrant that the assumptions underlying such forward-looking statements are error-free, nor do they assume any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecast developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. All ONWARD Medical medical devices and therapies mentioned herein, including but not limited to ARC-IM^®ARC-EX^®ARC-BCI™ and ARC Therapy™, are in the investigational stage and are not available for commercial use.